Avanos Recalls Catheters after 4 Injuries and 1 Death

Distributed from October 20, 2022, to January 23, 2023, BALLARD ACCESS Closed Suction System for Neonates/Pediatrics has two systems that have been recalled. The manifold of the BALLARD ACCESS Closed Suction System is a single-patient-use device that trained medical professionals use to provide access to the artificial airway without breaking the ventilation circuit in children, infants, or neonates. The BALLARD ACCESS Closed Suction manifold is used in conjunction with the BALLARD ACCESS Closed Suction catheter to clear away secretions from the artificial airway of children, infants, and neonates.

On February 22, 2023, Avanos Medical Inc. recalled 1,000 of the Avanos BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold or Elbow Manifold. Since the announcement of the recall, FDA has identified this as a Class I recall. A Class I recall is considered the most severe form of recall, and the continued use of the recalled devices can lead to severe injuries or death. The recall happened after Avanos received complaints from its customers over cracked manifolds during use. 

Cracked manifolds are dangerous, causing leaks in the respiratory circuit that can lead to the patient receiving inadequate ventilation. If the patient receives inadequate ventilation and oxygenation, it can lead to severe brain damage or even death. 

Additional risks from cracked manifolds include introducing a foreign body that could cause the following:

• Infection
• Damage to the airway 
• Blocked endotracheal tube

Avanos warns its customers that the continued use of this recalled product could lead to severe injury or death.

In the recall, it is noted that those directly affected are children, infants, and neonates who receive care by using a BALLARD ACCESS Closed Suction System. Others affected by the recall include the healthcare personnel providing care for those pediatric or neonatal patients who receive care by using a BALLARD ACCESS Closed Suction System.

Unfortunately, prior to the recall, there have been four reported injured and one death connected with the BALLARD ACCESS Closed Suction Systems.

On February 3, 2023, Avanos Medical Inc. sent their customers an “Urgent Medical Device Recall” letter outlining what they recommended their customers do if in possession of the recalled service devices. In light of the recall, customers are to do the following:

• Check all storage and usage locations for impacted BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold or with Elbow Manifold (labeled “72-hour use”).

• Quarantine all unused impacted products.

For the devices currently in use with patients:

• Check for cracks in the manifold of any product currently in use.

• Replace devices found to have cracked manifolds with a 24-hour use Ballard Closed Suction System for Neonates/Pediatrics.

• Use the 24-hour-use Ballard Closed Suction System for Neonates/Pediatrics for any new placements or scheduled placements.

Customers are expected to complete and return the Acknowledgement Response Form that was included in the letter and send it to FieldActioncare@avanos.com. Emails must include the subject line: FCA-2023-002 Hospital Acknowledgement Response Form.

As previously mentioned, Avanos customers will be contacted by their Customer Service to arrange for the product return, credit, and replacement after the acknowledgment form is submitted.

Yes. If you or a loved one have experienced an injury or have lost their life after using the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold or the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Elbow Manifold, we may be able to help you. 

For more information on how a Morgan & Morgan attorney can help you, please connect with us today by completing our free, no-obligation case evaluation form.